Labelling Harmonization 2011

Transcription

1 Labelling Harmonization 2011 DIA, Bethesda, MD Core Labeling During Clinical Development Su Yueh Lin Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual id presenter and should not be attributed t to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. i All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Drug Information Association 2 1

2 Topics: Various Core Labeling used during Clinical Development and their interrelationships How early to start and how and when to transition to core labeling for a development product Benefits of applying the principles of core labeling during clinical development Drug Information Association 3 Topics: Various Core Labeling used during Clinical Development and their interrelationships How early to start and how and when to transition to core labeling for a development product Benefits of applying the principles of core labeling during clinical development Drug Information Association 4 2

3 The CIOMS Working Group V proposes that the IB contain a section identical in structure to the Company Core Safety Information that is included in the Company Core Data Sheet for a marketed product, and that it be referred to as the Development Core Safety Information (DCSI). This would satisfy the need to help investigators and sponsors more effectively by presenting and updating a focused, dedicated Development Core Safety Information section that can conveniently be placed within the IB, perhaps as an Appendix. Furthermore, it is proposed that the DCSI develop into the CCSI that is included in the first Company Core Data Sheet for the product's entry into the market. [CIOMS working group V] Drug Information Association 5 During drug development, companies may have a variety of labeling related tools to Facilitate drug development with target labeling in mind Align desired marketing and labeling objectives with development program design (study design) Examples of these labeling tools during drug development (with no standard terminology): Investigator Brochure (IB) Target Labeling (TL)/ Target Profile Development Core Data Sheet () Development Core Safety Information (DCSI) CIOMS V FDA Target Product Profile (TPP) Others Drug Information Association 6 3

4 Types of Core Labeling during Clinical Development - IB vs CCDS IB CCDS Investigator s Brochure is the Predecessor of the CCDS Both IB and CCDS Represent Company s view of a product and its safety profile Are internal documents shared with external persons/institutions but are not fully public Are with multi-nation/region approach Drug Information Association 7 Types of Core Labeling during Clinical Development Development Core Data Sheet () vs Target Labeling (TL) IB CCDS TL (Development Core Data Sheet) for development labeling TL (Target Labeling)/Target Profile set of living objectives for the development team Both and TL are internal documents do not follow external format requirement Drug Information Association 8 4

5 Types of Core Labeling during Clinical Development Target Product Profile (TPP) and Draft SmPC IB TL TPP dsmpc TPP dsmpc CCDS TPP: FDA Target Product Profile dsmpc: Draft SmPC Both TPP and dsmpc are for discussion with Regulatory Agencies are based on and TL can follow FDA TPP format and EU SmPC format Drug Information Association 9 Types of Core Labeling during Clinical Development Development Core Safey Information (DCSI) vs Company Core Safety Information (CCSI) IB CCDS DCSI CCSI DCSI contains a set of evolving safety information including Expected events Anticipated events CI, W&P etc. CCSI contains a set of established safety information including ADRs/ IAs Anticipated ADRs/ IAs CI, W&P etc. IA: Interaction CI: Contraindication ADR: Adverse Drug Reaction W&P: Warnings and Precautions Drug Information Association

6 DCSI and CCSI See presentation in session 2, The Adverse Reactions and Interactions ti Section of a CCDS for definitions iti of adverse event or adverse reaction and the expectedness for safety reporting and labeling. Drug Information Association 11 Format and features of - example

7 Format and features of - example The format of the can be customized to accommodate the specific needs for a development project can contain, at the same time, the target and confirmed context, and anticipated local deviations 13 Topics: Various Core Labeling used during Clinical Development and their interrelationships How early to start and how and when to transition to core labeling for a development product Benefits of applying the principles of core labeling during clinical development Drug Information Association

8 When to start with a Development Labeling IB Pre-clin. PK First safety TL CCDS Early compound Phase1 Phase2 Phase3 Study results Phase3 Submission 15 Core Labeling Team Pharmacokinetics Pre-clinical Toxicology Global Pharmacovigilance and Epidemiology Clinical Quality Assurance Drug Regulatory Affairs (including CMC) * Control of CDS in one Labeling department or in Regulatory Medical Affairs and Marketing Legal 16 8

9 From to CCDS to Local Labeling When to start with a development labeling As soon as possible, as this can be used for agency discussions. US: Target Product Profile EU: Draft SmPC When to start drafting local labeling At some point of time add, at least, USPI and EU SmPC Depends on Project team but generally months before submission CCDS stays company opinion CCDS can be used to develop proposed USPI and EU SmPC, and keep them in line 17 From to CCDS to Local Labeling TL CCDS Interface Labeling Deliverables Pre-IND EOP*1 EOP2A EOP2/ Pre-Phase 3 Process Phase 3 CCDS Pre- NDA/BLA USPI SmPC Target Labeling Process *EOP: end of phase 18 9

10 From to CCDS to Local Labeling As early as possible Approx. 18 months US-PI CCDS EU- SmPC Internal approval Submission FDA Submission EMEA 19 From to CCDS to Local Labeling Early Phase(s) USPI EU-SmPC If needed USPI CCDS EU-SmPC Close(r) to submission 20 10

11 Topics: Various Core Labeling used during Clinical Development and their interrelationships How early to start and how and when to transition to core labeling for a development product Benefits of applying the principles of core labeling during clinical development Drug Information Association 21 Benefits of applying the principles of core labeling during clinical development Promote consistency in decision making across the development and marketing phases Identify gaps in development plan through Internal discussion Interaction with HAs Start early that you can influence the design of phase 3 trials and their statistical analysis Can be used for different target claims (indications), different audiences, and for different purposes Drug Information Association

12 Benefits of applying the principles of core labeling during clinical development - continued In addition to Core content, also prepare anticipated national deviations (content and wording), e.g., ADR section Drug Information Association 23 Questions? Drug Information Association